What is the Science Behind IvyGene's Cancer Detection?
DNA within cells can be modified by the addition of a methyl group (-CH3) to select sites within the genome. Depending on where the site is located within the genome, these DNA methylation sites can be indicators that a particular gene is being expressed (activated) or silenced (inactivated).
Consequentially, normal cells and cancer cells can be differentiated by detecting which of these sites within the genome are methylated. During malignant transformation (the process by which normal cells transform into cancer cells), there are significant changes in gene expression. These changes in gene expression are highly correlated to changes to the methylation pattern of genomic DNA.
The genomic DNA of cancer cells can be shed into circulation, usually due to cancer cell death (apoptosis or necrosis) or release from viable cells. Once the genomic DNA of a cancer cell is shed into the blood stream, it is called circulating tumor DNA (ctDNA).
The IvyGene test measures the methylation status of cell-free DNA extracted from blood samples at specific target sites that have been demonstrated to be hypermethylated when certain cancers are present.
What is the Accuracy of the IvyGene Test?
The sensitivity is approximately 83% for patients who have clinically confirmed breast, colon, liver or lung cancer and are not currently undergoing cancer treatment. These numbers are subject to change as the use for the IvyGene test to confirm the presence of cancer for additional cancer types is investigated.
The specificity is approximately 88%.
How Should the IvyGene Test Be Used and When Should I Recommend IvyGene?
The IvyGene test can provide additional insight and is supplementary to other standard of care diagnostics. It provides a non-invasive option to aid in the following:
Confirm specific cancer presence
Supplement other tests
Follow-up to other diagnostics and screening tests. Such as: abnormal imaging and BRCA1 and BRCA2.
Monitor for recurrence
Note: The IvyGene test is not classified a screening test.
The IvyGene® test is an adjunct clinical test that is intended to be based on the independent medical judgement of the ordering physician in conjunction with the patient’s complete medical history and the results of standard of care testing. The IvyGene® Test has been validated with four (4) cancer tissues of origin: breast, colon, liver and lung cancers. The presence of other cancer types may also result in an elevated IvyGene® Score. A large-scale clinical trial to demonstrate the efficacy of the IvyGene® Test as a cancer screening test has not been conducted. Cancer screening is not an approved utility of the IvyGene® test.
Cancers progress at varying rates and therefore, the frequency of diagnostic testing is subject to the ordering Provider’s clinical judgement.
Please, note that the IvyGene test does not “Stage” cancers, but rather provides quantifiable data about disease presence.